Sponsor study identifier
interventional
17
1 country
1
Study Start
May 6, 2022
Actual (reported)Primary Completion
August 4, 2022
Actual (reported)Study Completion
August 4, 2022
Actual (reported)This is a prospective, double-blind, randomised, sham-controlled study whose primary aim is to test whether LLLT changes the intensity of itch after histamine application in healthy volunteers compared to sham application.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 4, 2022
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 6, 2022
Actual (reported)May 6, 2022
Actual (reported)May 11, 2022
Actual (reported)August 4, 2022
Actual (reported)August 4, 2022
Actual (reported)Pruritus Intensity
Histaminergic itch is determined using a visual analogue scale (0-100) The non-histaminergic itch is determined by means of a visual analogue scale (0-100).
2 minutes
Neurogenic inflammation
10 minutes
Alloknesia
10 minutes
Hyperknesia
10 minutes
The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring.
The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.
The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.
Medical university of Graz
Graz, 8010, Austria
Lang-Illievich K, Klivinyi C, Schulze-Bauer H, Elhelali A, Bornemann-Cimenti H. The effect of photobiomodulation on histamine and Mucuna pruriens-induced pruritus, hyperknesis and alloknesis in healthy volunteers: A double-blind, randomized, sham-controlled study. PLoS One. 2024 Jul 18;19(7):e0307034. doi: 10.1371/journal.pone.0307034. eCollection 2024.
17 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2022
First Posted
May 11, 2022
Stimulating Compassion UsingTranscutaneous Vagus Nerve Stimulation
The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
May 6, 2022
Actual (reported)Primary Completion
August 4, 2022
Actual (reported)Study Completion
August 4, 2022
Actual (reported)Last Updated
August 15, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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